K042459 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT. This device is classified as a Assay, Glycosylated Hemoglobin (Class II - Special Controls, product code LCP).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 17, 2004, 68 days after receiving the submission on September 10, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7470.
| 510(k) Number | K042459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2004 |
| Decision Date | November 17, 2004 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7470 |